Onco-Summaries: Daily Oncology Updates at a Glance
21/10/2026
KEYTRUDA + Padcev receives EC approval for perioperative treatment of resectable MIBC (Ref)
Merck & Co./MSD announced that the European Commission approved KEYTRUDA® (pembrolizumab; anti-PD-1) + Padcev® (enfortumab vedotin-ejfv; nectin-4 targeted ADC) as perioperative treatment for adults with resectable muscle-invasive bladder cancer (MIBC)
Approval is based on results from the Phase 3 KEYNOTE-B15/EV-304 trial
The regimen demonstrated improved event-free survival (HR=0.53) and overall survival (HR=0.65) versus neoadjuvant gemcitabine/cisplatin followed by surgery
Pathologic complete response rates were 55.8% for KEYTRUDA plus Padcev versus 32.5% for gemcitabine/cisplatin
The approval covers use in adults with resectable MIBC regardless of cisplatin eligibility
The decision applies across EU member states, as well as Iceland, Liechtenstein, and Norway
US FDA grants Fast Track designation to Samsung Bioepis' SBE303 ADC for post-enfortumab vedotin advanced urothelial cancer (Ref)
Samsung Bioepis announced that the US FDA has granted Fast Track designation to SBE303 (nectin-4-targeting ADC), for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin
The asset is currently being evaluated in a Phase 1 clinical trial (NCT07524348)
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